Pediculicidal and ovacidal treatment compositions and methods for killing head lice and their eggs

ABSTRACT

The present invention relates to composition and methods for administering compositions in solutions for killing adult lice and the ova comprising water, PVM/MA Decadiene crosspolymers, propylene glycol, a mixture of cetyl and stearyl alcohols, Ceteareth-20; stearlkonium chloride; benzyl alcohol; hexylene glycol; pentylene glycol, isopropyl alcohol; a mixture of spinosyn A and spinosyn D in a weight ratio of 80:20, BHT; and sodium hydroxide.

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is a divisional of U.S. Ser. No. 09/841,715,filed Apr. 25, 2001.

FIELD OF THE INVENTION

[0002] The present invention relates to compositions and methods forcontrolling and treating adult lice and nits (or ova) of species of theorder of Anoplura, including but not limited to pediculus capitis,pediculus humanus and pthiris pubic, by applying a composition ofpediculicides and ovacides in solution to skin and hair, including butnot limited to human skin and hair. The compositions comprise effectivepediculicidal agents and ovacidal agents which are solubilized topromote penetration of the ova. More particularly, the effectivepediculicidal agents and ovacidal agents are spinosad, Spinosyn A,Spinosyn D, or combinations thereof.

BACKGROUND OF THE INVENTION

[0003] Lice present a source of serious health problems worldwide forman and animals. Not only do lice carry a variety of bacteria on theirouter surfaces, but in their fecal matter as well. Lice transmit thebacteria to their hosts through puncture wounds which are inflictedduring feeding, since lice must feed from their host's blood. Ailmentsranging from skin infections to typhus can be traced back to liceinfestation.

[0004] Lice belong to the order Anoplura. Specific species that affecthuman beings include pediculus capitis (head lice), pediculus humanus(body lice) and pthiris pubic (pubic lice). Lice are capable ofspreading rapidly. A fertilized female lays about six to eight eggs, ornits, every twenty-four hours. It has been estimated that a singlefemale louse and her daughters could have 112,778 offspring in a periodof forty-eight days.

[0005]Pediculus capitis clings to the hair shaft when feeding, mating,and laying eggs. Removal of nits is particularly difficult, as each nitis cemented to a shaft of hair by a glycoprotein glue, acting as abinding cement. Lice eggs themselves are covered by a chitinous sheathwhich surrounds both the nit and the attached hair shaft.

[0006] Various methods and compositions have been used to remove lice,for example mechanical removal with combs and chemical removal withinsecticides (known as pediculicides). Pediculicides, such as lindaneand various permethrins, have been used in conjunction with shampoos forkilling and rinsing out lice. However, as noted in the prior art, theuse of these methods and compositions is not entirely effective incontrolling head lice, as some lice often survive the treatment. Indeed,the National Pediculosis Association has reported that twenty to eightypercent of nits survive initial pediculicide treatment, resulting inreinfestation.

[0007] In the prior art, pyrethrum, permethrin, and lindane pesticides,all work as central nervous system toxins on lice. Their effectivenessdepends on their ability to reach the functioning central nervous systemon lice. Unfortunately, nits do not develop a functioning centralnervous system until they are between three and four days old, during anaverage incubation period of approximately ten days. As a result, onlysixty to seventy percent of nits treated can be killed upon applicationof one of these pediculicides.

[0008] Moreover, recently, lice may have begun to develop resistance tocurrent pediculicides. For example, resistance has already beendocumented in Europe, United States and Israel. Thus, a new active tokill lice and their eggs is desirable.

[0009] It has been discovered that Spinosyn A and Spinosyn D, compoundsthat have been used as insecticides for turf building and ornamentalplants may be used for killing lice. Spinosyn A and Spinosyn D arecomponents of a fermentation product derived from the bacterium speciesSaccharopolyspora spinosa. The bacteria decomposes much of the organicmatter in soil and the most active metabolites from this fermentationwere identified as Spinosyn A and D.

[0010] The chemical structure of spinosad contains two sugar molecules,one located at each end. A tetracyclic ring structure joins the twosugars. This structure is one of a class of compounds called macrolides.The chemical structure of spinosyns has the general formula of:

[0011] R is defined as any chemical group which provides pediculicidaland ovacidal properties, most preferably H and CH3.

[0012] It is known that Spinosyn A and Spinosyn D are useful asinsecticides against Lepidoptera and Diptera species. Spinosyns havebeen used in a pediculicidal shampoo. The prior art does not teach theuse of spinosyns in solution.

[0013] Known pediculicides have been noted to be ineffective on killingova. Thus, the use of these pediculicides results in a reinfestation ofthe hair or skin as soon as the ova hatch, since the treatment wasineffective in controlling and killing the ova. A need has arisen todevelop an effective treatment for both adult lice and their ova in acosmetically elegant form.

SUMMARY OF THE INVENTION

[0014] The present invention includes a composition comprising aneffective amount of one or more agents having pediculicidal and ovacidalproperties for adult lice and nits of a specie of order Anoplura insolution.

[0015] Another embodiment of the invention comprises pediculicidalagents and ovacidal agents in solution for adult lice and nits whichcomprise the chemical structure of:

[0016] In another embodiment, the present invention includes acomposition comprising a mixture of spinosyn A and spinosyn D in anapproximate weight ratio of 85:15, water, methyl vinyl ether/maleicanhydride crosslinked with 1,9 decadiene, propylene glycol, a mixture ofcetyl and stearyl alcohols, ceteareth-20, stearalkonium chloride, benzylalcohol, pentylene glycol, isopropyl alcohol, BHT and sodium hydroxide.

[0017] The present invention includes a method of controlling adults andova of the species of order Anoplura by topically applying to one ormore of skin and hair a composition comprising an effective amount ofone or more agents having pediculicidal and ovacidal properties foradult lice and nits of a specie of order Anoplura in solution. Thepediculicidal and ovacidal properties include the abilities to controladult lice and lice ova (or nits).

[0018] The present invention includes a method of controlling adults andova of the species of order Anoplura by topically applying to one ormore of skin and hair a composition comprising an effective amount ofone or more agents having pediculicidal and ovacidal properties foradult lice and nits of a specie of order Anoplura in solution, whichagents comprise the chemical structure of:

[0019] The present invention includes a method of controlling adults andova of the species of order Anoplura by topically applying to one ormore of skin and hair a composition comprising a mixture of spinosyn Aand spinosyn D in an approximate weight ratio of 80:20, water, methylvinyl ether/maleic anhydride crosslinked with 1,9 decadiene, propyleneglycol, a mixture of cetyl and stearyl alcohols, ceteareth-20,stearalkonium chloride, benzyl alcohol, pentylene glycol, isopropylalcohol, BHT and sodium hydroxide.

[0020] Another embodiment of the present invention includes a method ofcontrolling adults and ova of the species of order Anoplura by topicallyapplying to one or more of skin and hair a composition comprising about1 to about 2.2% of Spinosyn A & D in an approximate weight ratio of85:15, about 44% deionized water, about 1.1 Stabileze QM, about 3%propylene glycol, about 3% cetostearyl alcohol NF, about 0.9%Ceteareth-20, about 4.17% stearalkonium chloride (or Ammonyx 4 (18%)),about 10% benzyl alcohol, about 6% hexylene glycol, about 4% pentyleneglycol, about 20% isoproyl alcohol, about 0.1% BHT and about 1.2 toabout 1.9% sodium hydroxide (10% solution).

[0021] A further separate embodiment of the present invention is amethod for solubilizing agents having pediculicidal and ovacidalproperties comprising combining one or more solvents and an effectiveamount of one or more agents having pediculicidal and ovacidalproperties; wherein the agents comprise a chemical structure of:

DETAILED DESCRIPTION OF THE INVENTION

[0022] The present invention relates to a composition comprising aneffective amount of agents with pediculicidal and ovacidal properties ina cosmetically elegant solution or emulsion, including but not limitedto imidacloprid, spinosad, a spinosyn, Spinosyn A, Spinosyn D, anycomponent produced from the Saccharopolyspora spinosa species orcombinations. Additionally, the present invention includes the method ofapplying a pediculicide and ovacide composition in solution to hair orskin for the control of adults and nits of a specie of the orderAnoplura.

[0023] Spinosyn A and Spinosyn D are also known as A83543A and A83543Drespectively. Both Spinosyn A and Spinosyn D are the major components ofa fermentation product known as A83543. This fermentation product,A83543, is produced by the species Saccharopolyspora spinosa.

[0024] What is meant by “an effective amount” refers to an amount ofimidacloprid, spinosad, spinosyn, Spinosyn A, Spinosyn D or acombination thereof sufficient to decrease the number of live lice andviable nits, i.e. eggs. The effective amount can typically range fromgreater than about 0% to about 10%, preferably, about 0.5% to about 5%.(All percentages in this disclosure are weight percentages.)

[0025] When “effective amount” refers to solvents, solubilizing agentsor solutions, the term means that the solvents solubilize thepediculicidal agents and ovacidal agents and also that the solution hasa concentration that effectively controls the lice and ova.

[0026] What is meant by “skin” refers to that of an animal, preferably amammal, most preferably a human. Skin that would be commonly prone tonits includes that of the scalp, body, and pubis areas.

[0027] What is meant by “to control” is to reduce the number of viablenits and live lice. The extent of reduction accomplished by thecomposition depends upon the application rate of the composition, thechoice of imidacloprid, spinosad, spinosyn, Spinosyn A, Spinosyn D, anycomponent produced from the Saccharopolyspora spinosa species and acombination thereof, and the species of Anoplura targeted.

[0028] The order Anoplura includes the following families:echniophtiriidae, enderleinellidae, haematopinidae, linognathidae,pecaroecidae, pediculidae, polyplacidae, and pthiridae. Examples ofspecies in the order Anoplura include, but are not limited to pediculushumanus, pediculus capitis, and pthiris pubis. These three species areknown more commonly as the body louse, head louse, and pubic louse.

[0029] What is meant by “solubilizing agent” or “solvent” refers tosolvents capable of solubilizing the pediculicides and ovacides,preferably in the minimum amount required to solubilize thepediculicides and ovacides, preferably about 3% propylene glycol, about10% benzyl alcohol, about 6% hexylene glycol, about 4% pentylene glycol,and about 20% isopropyl alcohol. Examples of solubilizing agentsinclude, but are not limited to, glycols, for example, propylene glycol,polyethylene glycol, dipropylene glycol, pentylene glycol, andmethoxypolyethylene glycol, hexylene glycol, butylene glycol; benzylalcohol; isopropyl alcohol; preferably penetylene glycol; combinationsof pentylene glycol, benzyl alcohol and isopropyl alcohol, either withor without one of the following: hexylene glycol, butylene glycol,dipropylene glycol, methoxypolyethylene glycol or propylene glycol; orcombinations of hexylene glycol, butylene glycol, benzyl alcohol andisopropyl alcohol (“Solvent Matrices”). These Solvent Matrices arecapable of solubilizing poorly soluble drugs, including but not limitedto imidacloprid, spinosad, spinosyn, spinosyn A, spinosyn D, anycomponent produced by the Saccharopolyspora spinosa species and acombination thereof. These Solvent Matrices have the additional functionof aiding in the penetration of the ova of the louse.

[0030] The compositions of this invention comprise an effective amountof pediculicidal agents and ovacidal agents in solution, used forcontrolling lice and its ova. The solvents are beneficial because theysolubilize the pediculicidal agents and ovacidal agents, and alsopromote the penetration of the ova so that the ovacidal agents arehighly effective. Without being bound by a mechanism, the presentinvention is believed to better penetrate lice and its ova.Additionally, the compositions of this invention are cosmeticallyelegant. The preferred solvents are benzyl alcohol, pentylene glycol,isopropyl alcohol, hexylene glycol, butylene glycol, dipropylene glycoland combinations thereof. More particularly, the pediculicidal agentsand ovacidal agents may be, including but not limited to imidacloprid,spinosad, spinosyn, Spinosyn A, Spinosyn D, any component produced fromthe Saccharopolyspora spinosa species or a combination thereof. Thepreferred pediculicidal agent and ovacidal agent is a combination ofSpinosyn A and Spinosyn D in a weight ratio of 85/15 or 80/20.

[0031] The compositions disclosed in this patent have an improvedsolubility of pediculicides and ovacides, including but not limited toimidacloprid, spinosad, spinosyn, Spinosyn A, Spinosyn D, any componentproduced from the Saccharopolyspora spinosa species or a combinationthereof, which yields a more effective pediculicide and ovacide for thespecie of the order of Anoplura. Specific species that affect humanbeings include pediculus capitis (head lice), pediculus humanus (bodylice) and pthiris pubic (pubic lice).

[0032] More particularly, the pediculicides and ovacides are present ina composition with solvents and stabilizers. The solvents may helppromote the penetration of the composition into the ova in order to actlike a ovacide, in addition to being a pediculicide.

[0033] In one embodiment, the invention features a compositioncomprising an effective amount of one or more pediculicidal and ovacidalproperties, which may include but is not limited to imidacloprid,spinosad, spinosyn, Spinosyn A, Spinosyn D, any component produced fromthe Saccharopolyspora spinosa species or a combination thereof; water;benzyl alcohol; hexylene glycol; pentylene glycol; butylene glycol;dipropylene glycol; isopropyl alcohol; and a non-acrylic stabilizer, forexample, a co-polymer of methyl vinyl ether/maleic anhydridecross-linked with 1,9-decadiene. This composition is beneficial becauseit is capable of solubilizing the pediculicidal and/or ovacidal agents,which results in high mortality of adult lice and their ova.

[0034] In one embodiment, the solubilizing agents of the composition mayinclude glycols, for example, propylene glycol, polyethylene glycol,dipropylene glycol, pentylene glycol, and methoxypolyethylene glycol,hexylene glycol, butylene glycol; benzyl alcohol; isopropyl alcohol;preferably penetylene glycol; combinations of pentylene glycol, benzylalcohol and isopropyl alcohol, either with or without one of thefollowing: hexylene glycol, butylene glycol, dipropylene glycol,methoxypolyethylene glycol or propylene glycol; or combinations ofhexylene glycol, butylene glycol, benzyl alcohol and isopropyl alcohol.

[0035] The present invention also relates to a composition comprising aneffective amount of one or more pediculicides and ovacides for nits andadult lice (collectively “Lice”) of a specie of the order Anoplura and asolubilizing agent. The pediculicides and ovacides are ingredients whichcontrol the Lice, including but not limited to any component produced bythe Saccharopolyspora spinosa species, imidacloprid (also known as NTN33893, which is a proprietary chemical of Bayer AG), spinosad, spinosyn,Spinosyn A and Spinosyn D, and a combination thereof, preferably amixture of Spinosyn A and Spinosyn D in an approximate weight ratio of80:20. The preferable amount of stabilizers is between about 0.5 toabout 1.5%.

[0036] What is meant by “cleansing surfactants” is one or more compoundsused for skin and/or hair cleaning, and the cleansing surfactants areused in an amount which produces the desired function provided that theamount does not effect the stability of the solution. These compoundscan also serve as cosmetic emulsifiers. Classes of compounds includesoaps and fatty acids/alkali combinations. Examples include, but are notlimited to, ammonium lauryl sulfate, ammonium laureth sulfate, sodiumlauryl sulfate, sodium laureth sulfate. For a more complete listing ofcleansing surfactants, herein incorporated by reference, see CFTADictionary 1789-1795.

[0037] What is meant by “emulsifying surfactants” is one or morecompounds that reduce surface tension and the emulsifying surfactantsare used in an amount which produces the desired function provided thatthe amount does not effect the stability of the solution. They createbarriers around droplets to prevent them from coalescing. Emulsifierscould be, but are not limited to oil-in-water emulsifiers, water-in-oilemulsifiers, water-in-oil-in-water emulsifiers, oil-in-water-in-oilemulsifiers, silicone-in-water emulsifiers, and water-in-siliconeemulsifiers. Examples include, but are not limited to, glyceryltrioleate, acetylated sucrose distearate, sorbitan trioleate,polyoxyethylene (1) monostearate, glycerol monooleate, sucrosedistearate, polyethylene glycol (50) monostearate, octyl phenoxypoly(ethyleneoxy) ethanol, deacylerin penta-isostearate, sorbitansesquioleate, hydroxylated lanolin, lanolin, triglyceryl diisostearate,polyoxyethylene (2) oleyl ether, calcium stearoyl-2-lactylate, cetearylglucoside, methyl glucoside sesquistearate, sorbitan monopalmitate,methoxy polyethylene glycol-22/dodecyl glycol copolymer, polyethyleneglycol-45/dodecyl glycol copolymer, polyethylene glycol 400 distearateand glyceryl stearate, cetyl phosphate, potassium cetyl phosphate. Seealso CTFA Dictionary 1796-1803.

[0038] What is meant by “foam-boosting surfactants” is one or morecompounds that have the ability to either generate or stabilize foamsand the foam-boosting surfactants are used in an amount which producesthe desired function provided that the amount does not effect thestability of the solution. They generally increase the surface viscosityof the vehicle surrounding the bubbles. Examples of foam-boostingsurfactants include, but are not limited to, cocamidoethyl betaine,cetyl betaine, disodium cetearyl sulfosuccinate, disodiumoleoamphodipropionate, lauramide DEA, lauramidopropyl betaine. See alsoCTFA Dictionary, 1803-1804.

[0039] What is meant by “emollient skin conditioning agents” is one ormore compounds that soften and smooth the skin and the emollient skinconditioning agents are used in an amount which produces the desiredfunction provided that the amount does not effect the stability of thesolution. These compounds achieve this effect lubricating the skinsurface, encouraging skin water retention, and altering producttextures. Examples include, but are not limited to, octylhydroxystearate, lanolin, capric/caprylic triglyceride, cetyl palmitate,cetyl alcohol, isopropyl isostearate, glyceryl dilaurate, isopropylmyristate, palm alcohol, and sucrose cocoate. See also CTFA Dictionary1768-1773.

[0040] What is meant by “humectants” is one or more compounds thatprevent the skin from losing moisture and the humectants are used in anamount which produces the desired function provided that the amount doesnot effect the stability of the solution. Examples include, but are notlimited to, glycerin, glucose, honey, lactic acid, polyethylene glycol,propylene glycol, sorbitol, sucrose, and trehalose. See also CTFADictionary 1773-1774.

[0041] What is meant by “buffering agents” is one or more compounds thatcan maintain a desired pH in an aqueous environment and the bufferingagents are used in an amount which produces the desired functionprovided that the amount does not effect the stability of the solution.Examples include, but are not limited to, boric acid, citric acid,lactic acid, fumaric acid, phosphoric acid, and salts thereof. See alsoCTFA Dictionary 1733-1734.

[0042] What is meant by “chelating agents” is one or more compounds thatcan complex and subsequently inactivate ions in the formulation and thechelating agents are used in an amount which produces the desiredfunction provided that the amount does not effect the stability of thesolution. Examples include, citric acid, disodium edetate,pentapotassium triphosphate, and phytic acid. See also CTFA Dictionary1734-1735.

[0043] What is meant by “preservatives” is one or more compounds thatprevent or reduce or slow down microbial growth and the preservativesare used in an amount which produces the desired function provided thatthe amount does not effect the stability of the solution. Examplesinclude, but are not limited to, benzoic acid, butylparaben,ethylparaben, propylparaben, methylparaben, sorbic acid, phenoxyethanol,and triclosan. See CTFA Dictionary 1765-1766.

[0044] pH Adjusters are also present in some embodiments of theinvention and the pH Adjusters are used in an amount which produces thedesired function provided that the amount does not effect the stabilityof the solution. “pH adjuster” are acids or bases that can be used toadjust the pH of the finished product to the desired level. Examplesinclude, but are not limited to, acetic acid, ammonia, citric acid,ethanolamine, formic acid, oxalic acid, potassium hydroxide, sodiumhydroxide, and triethanolamine. See also Wenniger and McEwen, eds., 2International Cosmetic Ingredient Dictionary and Handbook 1764 (2000ed.) (hereinafter “CFTA Dictionary”). All cited references in thisapplication are herein incorporated by reference.

[0045] Further an embodiment of the invention may include one or moremoisturizers, preferably propylene glycol and the moisturizers are usedin an amount which produces the desired function provided that theamount does not effect the stability of the solution. Additionally,emulsifying agents may be desirable, preferably Ceteareth-20,manufactured by Promateen Chemicals Inc., which is a polyethylene glycolether of cetearyl alcohol. Ceteareth-20 has 20 moles of ethylene oxidewhich is added to the non-ionic surfactant to increase its watersolubility. In the event that an emulsion stabilizer is used, thepreferred one is a mixture of cetyl and stearyl alcohols, sold by CrodaInc. under the name Cetearyl alcohol.

[0046] In order to prevent the degradation caused by oxidation,antioxidants may be included in the formulation and the antioxidants areused in an amount which produces the desired function provided that theamount does not effect the stability of the solution. Antioxidantsinclude, but are not limited to free radical scavengers and reducingagents such as, acetyl cysteine, ascorbic acid, butylatedhydroxytoluene, green tea extract, caffeic acid, cysteine, tocopherol,ubiquinone, and propyl gallate, preferably butylated hydroxytoluene(“BHT”). See CFTA Dictionary 1727.

[0047] What is meant by “hair conditioning agents” or “conditioningagents” are compounds that can alter the texture, appearance, styling,or feel of the hair and the conditioning agents are used in an amountwhich produces the desired function provided that the amount does noteffect the stability of the solution. Examples include, but are notlimited to, alanine, arginine, biotin, calcium panthothenate,dimethicone, cyclomethicone, hydrolyzed plant protein, andpolyquaterniums, preferably stearalkonium chloride, sold under the nameAmmonyx-4 by Stepan Company. See CFTA Dictionary 1752-1759.

[0048] In other embodiments, in addition to the pediculicides, ovacidesand Solvent Matrices, these compositions can further comprise adjuvantsand the adjuvants are used in an amount which produces the desiredfunction provided that the amount does not effect the stability of thesolution. Examples of adjuvants include, but are not limited tovehicles, stabilizers, moisturizers, cleansing surfactants, emulsifyingsurfactants, emulsifying stabilizers, foam-boosting surfactants,emollient skin conditioning agents, humectants, hair conditioningagents, buffering agents, pH adjusters, chelating agents, antioxidants,preservatives, botanical extracts, fragrances, and dyes.

[0049] In another embodiment, the composition includes one or morepediculicide and ovacide, the Solvent Matrices, and one or morestabilizers to prevent physical separation of the formulation(“Stabilizers”). Non-acrylic decadiene crosspolymers, including but notlimited to Stabileze QM and Stabileze 06 (preferably Stabileze QM)manufactured by International Specialty Products may be employed tostabilize and optionally to thicken the formulations. Stabileze QM andStabileze 06 are benzene-free copolymers of methyl vinyl ether/maleicanhydride crosslinked with 1,9-decadiene. The INCI name for Stabileze 06and Stabileze QM is PVM/MA Decadiene crosspolymers. Stabileze 06 has aparticle size of <850μ. Stabileze QM has a particle size of <75μ. SinceStabileze QM has a smaller particle size, it may be dispersed fasterthan Stabileze 06 and may be more rapidly converted to a gel. In someembodiments, a neutralizer of the stabilizer may be required toneutralize the formulation to an approximate pH of 5.5 in order to allowthickening of the formulation. A preferred neutralizer is sodiumhydroxide.

[0050] Stabilizers may also include but are not limited toacrylates/aminoacrylates C10-30 Alkyl PEG-20 Itaconate copolymer, longchain acyl derivatives (including but not limited to ethylene glycoldistearate and ethylene glycol monostearate), alkanoamides (includingbut not limited to cocamide MEA), esters of long chain fatty acids(including but not limited to stearyl stearate), alkyl dimethylamineoxides, methylcellulose, hydroxybutyl methylcellulose,hydroxypropylcellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, distearyl phthalic amide (e.g. Stephan SAB-2),di(hydrogenated) tallow phthalic amide (e.g. Stephan TAB-2), primaryamines with a fatty alkyl moiety of at least 16 carbons (including butnot limited to palmitate amine or stearamine), polyacrylic acids,polysaccharide gums (including but not limited to Xanthan Gum),colloidal clays (including but not limited to benzyl dimethylhydrogenated tallow ammonium montmorillonite) and colloidal silica.

[0051] One of the preferred embodiments is in the form of a conditioneror cream rinse for human hair or animal hair. Hair conditioning agentsmay be included in the formulation.

[0052] The compositions can be administered topically to an animal, bythe direct laying on or spreading of the composition on the skin orhair, preferably of a mammal, most preferably of a human. Thecompositions useful in the subject invention involve formulationssuitable for topical application to mammalian skin or hair.Additionally, the compositions may be made into a wide variety ofproduct types. These include, but are not limited to solutions,aerosols, lotions, creams, gels, sticks, ointments, pastes, creamrinses, shampoos, and body washes. The preferred embodiments are creamrinses, conditioners and shampoos.

[0053] Vehicles include but are not limited to water, propylene glycol,butylene glycol, ethanol, isopropanol, silicones. Preferably, thevehicle is water.

[0054] The invention will be clarified further by a consideration of thefollowing examples.

EXAMPLE 1 Testing of Spinosyn A and Spinosyn D on Pediculis CaptitisEggs

[0055] Both Spinosyn A and Spinosyn D are sold together as the activeingredient for Conserve SC. Conserve SC is a commercial product fromDowElanco used for insect control of turf and ornamental plants. Thecombination of Spinosyn A and Spinosyn D is known as Spinosad. ConserveSC contains 11.60%, by weight, of the Spinosad. Spinosad containsapproximately 80% Spinosyn A and 20% Spinosyn D. Three dilutions of theConserve SC were created:

[0056] Dilution 1 contained 8.62% Conserve SC, 15% isopropanol, 10%propylene carbonate, and 53.45% deionized water. Dilution 1 resulted ina 1% Spinosad concentration.

[0057] Dilution 2 contained 21.55% Conserve SC, 15% isopropanol, 10%propylene carbonate, and 66.38% deionized water. Dilution 2 resulted ina 2.5% Spinosad concentration.

[0058] Dilution 3 contained 43.10% Conserve SC, 15% isopropanol, 10%propylene carbonate, and 31.9% deionized water. Dilution 3 resulted in a5% Spinosad concentration.

[0059] An in vitro test of Dilutions 1, 2, and 3 was conducted usingfresh specimens of pediculus capitis eggs. Specimens were collected fromvolunteers who had abundant nits. Collected eggs were examined forviability. A viable egg is shiny, plump, with an intact operculum, andin more developed eggs, an eye spot. Eggs that were dry, shrunken,indented or otherwise damaged were rejected, as were any eggs containingair pockets.

[0060] The ovacidal assay was conducted at ambient room temperature (25°to 35° C.) and humidity (70-90% RH). Ten hairs with viable eggs weresandwiched between small adhesive labels, allowing 2 cm of the hairs toprotrude, with the eggs aligned at the distal end. Immediately prior totesting, the dilutions were shaken thoroughly and dispensed into cleanglass vials. The eggs were completely immersed in the formulations forten minutes. Following immersion, the hair and eggs were rinsed in agentle stream of filtered water from a squeeze bottle to simulatenatural shower conditions. They were allowed to air dry for 30 minutesbefore being placed in capped vials for incubation at 28° to 32° C., RH70-90%.

[0061] Ten batches of ten eggs were tested for each dilution for a totalof one hundred eggs for each dilution. One hundred untreated eggs andone hundred eggs immersed in water were used as controls.

[0062] Another set of ten batches of ten eggs each (for a total of 100eggs) were tested on three successive days. After immersion and rinsing,these eggs were allowed to air dry, and then stored in separate, glassvials. The same eggs were tested on three consecutive days and then leftto incubate for two weeks.

[0063] Ovacidal activity was recorded as number of eggs tested, numberof eggs hatched, number of eggs not hatched, and number of eggsstillborn. What was meant by “stillborn” referred to the nymphs thatreach maturity, are able to lift the operculum, or cap of the egg, butare unable to filly emerge. These stillborn eggs were considerednon-viable.

[0064] All three dilutions demonstrated good ovacidal activity. Nosignificant difference in the activity of the dilutions were observed.There was no significant difference between a single treatment of 10minutes followed by rinsing and a 10-minute treatment on threeconsecutive days (=3 treatments). The high hatch rates (96% to 98%) ofthe eggs treated with water in the identical manner as the dilutionsindicate that every aspect of the conduct of the test was optimal,including the selection of eggs by the collecting teams, protection ofthe eggs from heat, lack of contamination by toxic agents on the handsof the collectors and the investigators, and the incubation conditions.Table 1 shows the ovacidal activity for the single 10-minute immersionfollowed by a water rinse and two week incubation. Table 2 shows theovacidal activity for 10-minute immersion on three successive daysfollowed by two week incubation. TABLE 1 # of Eggs # of Eggs # of Eggs #of Eggs % of Eggs Dilution Tested Hatched Not Hatched Stillborn HatchedDilution 1 100 1 96 3 1% (1% Spinosad) Dilution 2 100 0 96 4 0% (2.5%Spinosad) Dilution 3 100 2 92 6 2% (5% Spinosad) Water 100 96 4 0 96%Untreated 110 105 5 0 95%

[0065] TABLE 2 # of Eggs # of Eggs # of Eggs # of Eggs % of EggsDilution Tested Hatched Not Hatched Stillborn Hatched Dilution 1 100 0100 0 0% (1% Spinosad) Dilution 2 100 0 98 2 0% (2.5% Spinosad) Dilution3 100 0 99 1 0% (5% Spinosad) Water 100 98 2 0 98%

EXAMPLE 2 In-Vitro Ovacidal Testing

[0066] In vitro tests were conducted on human head lice with sixformulations in order to study the pediculicidal and ovacidal activityof the formulations. No human subjects were used. The ovacidal resultswere as follows: TABLE 3 Active Single Exposure Double ExposureDescription Ingredient % Ovacidal Rate Ovacidal Rate Cream Rinse A 1%Spinosad 80% 100% Cream Rinse A1 2% Spinosad 95% 100% Cream Rinse B 1%Spinosad 85%  84% Cream Rinse C 1% Spinosad 76%  94% Nix ® (control) 1%Permethrin 76%  58% Deionized Water 11%  8%

[0067] TABLE 4 Cream Cream Cream Cream Trade Name INCI Name Rinse ARinse A1 Rinse B Rinse C Deionized Water 44.8 44.25 44.82 44.81Stabileze PVM/MA 1.1 1.1 1.1 1.1 QM Decadiene Crosspolymer PropylenePropylene 3 3 3 3 Glycol Glycol Cetostearyl Cetearyl alcohol 3 3 3 3Alcohol NF Procol-CS- Ceteareth-20 0.9 0.9 0.9 0.9 20 Ammonyx 4Stearalkonium 4.17 4.17 4.17 4.17 (18%) Chloride Benzyl Benzyl Alcohol10 10 10 10 Alcohol Hexylene Hexylene Glycol 6 6 — — Glycol ButyleneButylene Glycol — — 5 — Glycol Dipropylene Dipropylene — — — 5 GlycolGlycol Hydrolite-5 Pentylene 4 4 5 5 Glycol Isopropyl Isopropyl 20 20 2020 alcohol alcohol Spinosad Spinosyn A & D 1.095 2.19 1.095 1.095(91.4%)

[0068] BHT Butylated 0.1 0.1 0.1 0.1 Hydroxytoluene Sodium Sodium 1.831.29 1.81 1.82 Hydroxide Hydroxide (10% soln.) 100 100 100 100

[0069] In this test, Single Exposure means that the ova were exposed tothe formulation for 10 minutes on Day 1, Double Exposure means that theova were exposed to the formulation for 10 minutes on Day 1 and Day 4.Ovacidal Rate means the percent of louse ova unhatched after a 14 dayincubation period.

[0070] Therefore, all of the cream rinses effectively deliver Spinosadinto the louse ova resulting in strong ovacidal activity. Doubleexposures of Cream Rinse A and Cream Rinse A1 are most effective with100% mortality rates of the ova in-vitro, while double exposures of anylevel of Spinosad increases ovacidal effectiveness. Finally, Spinosad 1%and 2% formulations are superior to Nix®. Nix® is the prior art licetreatment currently marketed to treat lice infestation.

EXAMPLE 3 In-Vitro Pediculicidal Testing

[0071] The following are results taken for the same formulations asExample 3 as tested on adult lice for the pediculicidal rates. TABLE 5Single Exposure Single Exposure 1-Minute Immersion 10-Minute ImmersionActive % % Ingredient % % Alive % % Alive Formulation % Dead Moribund &Well Dead Moribund & Well A2 0.5% 77% 23% — 100% — — Spinosad A 1% 92% 8% — 100% — — Spinosad A1 2% 82% 18% — 100% — — Spinosad B 1% 92%  8% — 97% 3% — Spinosad C 1% 87% 13% — 100% — — Spinosad Nix® 1% 92%  8% — 92% 8% — Permethrin Deionized —  3% —  97%  2% — 98% Water

[0072] All measurements on this chart were taken at 4 hours afterexposure. Moribund means that the lice were in terminal stages of life,from which they can never recover any useful function. In this phase,the lice may show signs of central nervous system or peripheral nervetoxicity, such as tremors, convulsions or twitching of a leg or antenna.

[0073] From this study, one can conclude that 0.5%, 1% and 2% Spinosaddeliver excellent pediculicidal activity at 1-minute and 10-minuteexposure times. Formulations A, A1 and A2 have superior pediculicidalactivity to Nix® after a 10-minute immersion time. TABLE 6 Trade NameINCI Name Cream Rinse A2 Placebo Deionized Water 45.022 46.046 StabilezeQM PVM/MA Decadiene 1.1 1.1 Crosspolymer Propylene Glycol PropyleneGlycol 3 3 Cetostearyl Alcohol NF Cetearyl alcohol 3 3 Procol-CS-20Ceteareth-20 0.9 0.9 Ammonyx 4 (18%) Stearalkonium Chloride 4.17 4.17Benzyl Alcohol Benzyl Alcohol 10 10 Hexylene Glycol Hexylene Glycol 6 6Butylene Glycol Butylene Glycol — — Dipropylene Glycol DipropyleneGlycol — — Hydrolite-5 Pentylene Glycol 4 4 Isopropyl alcohol Isopropylalcohol 20 20 Spinosad (91.4%) Spinosyn A & D 0.548 — BHT ButylatedHydroxytoluene 0.1 0.1 Sodium Hydroxide (10% Sodium Hydroxide 2.16 1.684soln.)

[0074] Since it is critical that the compositions of this invention arenot irritants to human skin, we performed a Draize sensitization study(repeat insult patch test) using a placebo (described in the tableabove) for one of the vehicles. 100 human subjects were involved for 5weeks. No subject showed sensitization when the vehicle was applied tothe skin.

[0075] It is understood that while the invention has been described inconjunction with the detailed description thereof, that the foregoingdescription is intended to illustrate and not limit the scope of theinvention, which is defined by the scope of the appended claims. Otheraspects, advantages, and modifications are evident from a review of thefollowing claims.

What is claimed is:
 1. A composition comprising: an effective amount ofone or more agents having pediculicidal and ovacidal properties foradult lice and nits of a specie of order Anoplura in solution; whereinthe agents comprise a chemical structure of:


2. The composition of claim 1 further comprising one or morestabilizers.
 3. The composition of claim 1, wherein the agents consistof one or more of the following: spinosad, spinosyn A, spinosyn D, anycomponent produced by the Saccharopolyspora spinosa species and acombination thereof.
 4. The composition of claim 1 wherein R comprisesH.
 5. The composition of claim 1 wherein R comprises CH₃.
 6. Thecomposition of claim 1 wherein R comprises a mixture of H and CH₃. 7.The composition of claim 1 wherein R comprises a mixture of H:CH₃wherein the relative structures are in a weight ratio of approximately85:15.
 8. The composition of claim 1 wherein the agents comprise greaterthan about 0 to about 10 percent of the composition.
 9. The compositionof claim 1 wherein the agents comprise between about 0.5 to about 5percent of the composition.
 10. The composition of claim 2, wherein thestabilizers comprise one or more of the group consisting of PVM/MADecadiene crosspolymers, acrylates/aminoacrylates C10-30 Alkyl PEG-20Itaconate copolymer, long chain acyl derivatives, alkanolamides, estersof long chain of fatty acids, alkyl dimethylamine oxides,methylcellulose, hydroxybutyl methylcellulose, hydroxypropylcellulose,hydroxypropyl methylcellulose, hydroxethyl cellulose, distearyl phthalicamide, di(hydrogenated) tallow phthalic amide, primary amines with afatty alkyl moiety of at least 16 carbons, polyacrylic acids,polysaccharide gums, colloidal clays and colloidal silica.
 11. Thecomposition of claim 2, wherein the stabilizers comprise PVM/MADecadiene crosspolymers.
 12. The composition of claim 2 wherein thestabilizers comprise about 0.5 to about 1.5 percent of the composition.13. The composition of claim 2 wherein the stabilizers have a particlesize of less than 75μ.
 14. The composition of claim 1, wherein thesolution further comprises a solvent consisting of one or more of thefollowing: benzyl alcohol, pentylene glycol, isopropyl alcohol, hexyleneglycol, butylene glycol, and dipropylene glycol.
 15. The composition ofclaim 1 further comprising: one or more stabilizers; one or moremoisturizers; one or more emulsion stabilizers; one or more emulsifyingagents; one or more conditioning agents; one or more antioxidants; andone or more pH adjuster.
 16. The composition of claim 15 wherein themoisturizer comprises propylene glycol.
 17. The composition of claim 15wherein the emulsion stabilizer comprises a mixture of cetyl and stearylalcohols.
 18. The composition of claim 15 wherein the emulsifying agentcomprises Ceteareth-20.
 19. The composition of claim 15 wherein theconditioning agent comprises stearalkonium chloride.
 20. The compositionof claim 15 wherein the antioxidant comprises BHT.
 21. The compositionof claim 15 wherein the pH adjuster comprises sodium hydroxide.
 22. Thecomposition of claim 15 further comprising one or more viscosityincreasing agents.
 23. The composition of claim 22 wherein the viscosityincreasing agent comprises a mixture of cetyl and stearyl alcohols. 24.A composition comprising: an effective amount of one or more agentshaving pediculicidal and ovacidal properties for adult lice and nits ofa specie of order Anoplura in solution; wherein the agents comprise achemical structure of:

and one or more stabilizers.
 25. A composition comprising: About 44%water; About 1.1% PVM/MA Decadiene crosspolymers; About 3% propyleneglycol; About 3% cetearyl alcohol; About 0.9% ceteareth-20; About 4.17%stearalkonium chloride; About 10% benzyl alcohol; About 6% hexyleneglycol; About 4% pentylene glycol; About 20% isopropyl alcohol; About2.19% mixture of spinosyn A & D in an approximate 85:15 weight ratio;About 0.1% BHT; and About 1.29% sodium hydroxide (10% solution).
 26. Acomposition comprising: Water; A PVM/MA Decadiene crosspolymers;Propylene glycol; A mixture of cetyl and stearyl alcohols; Ceteareth-20;Stearalkonium chloride; Benzyl alcohol; Pentylene glycol;′ Isopropylalcohol; A mixture of spinosyn A and spinosyn D in a weight ratio ofapproximately 85:15; BHT; and Sodium hydroxide.
 27. A method ofcontrolling adults and ova of the species of order Anoplura by topicallyapplying to one or more of skin and hair a composition comprising: aneffective amount of one or more agents having pediculicidal and ovacidalproperties in solution; wherein the agents comprise a chemical structureof:


28. The method of claim 27 wherein the composition further comprises oneor more stabilizers.
 29. The method of claim 27, wherein the agentsconsist of one or more of the following: spinosad, spinosyn, spinosyn A,spinosyn D, any component produced by the Saccharopolyspora spinosaspecies and a combination thereof.
 30. The method of claim 27, wherein Rcomprises H.
 31. The method of claim 27, wherein R comprises CH₃. 32.The method of claim 27, wherein R comprises a mixture of H:CH₃.
 33. Themethod of claim 27, wherein R comprises a mixture of H:CH₃ wherein therelative structures are in a weight ratio of approximately 85:15. 34.The method of claim 27, wherein the agents comprise greater than about 0to about 10 percent of the composition.
 35. The method of claim 27wherein the agents comprise between about 0.5 to about 5 percent of thecomposition.
 36. The method of claim 28, wherein the stabilizerscomprise one or more of the group consisting of PVM/MA Decadienecrosspolymers, acrylates/aminoacrylates C10-30 Alkyl PEG-20 Itaconatecopolymer, long chain acyl derivatives, alkanolamides, esters of longchain of fatty acids, alkyl dimethylamine oxides, methylcellulose,hydroxybutyl methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, hydroxyethyl cellulose, distearyl phthalic amide,di(hydrogenated) tallow phthalic amide, primary amines with a fattyalkyl moiety of at least 16 carbons, polyacrylic acids, polysaccharidegums, colloidal clays and colloidal silica.
 37. The method of claim 28,wherein the stabilizer comprise PVM/MA decadiene crosspolymers.
 38. Themethod of claim 28 wherein the stabilizers comprises about 0.5 to about1.5 percent of the composition.
 39. The method of claim 28 wherein thestabilizers have a particle size of <75μ.
 40. The method of claim 27,wherein the solution further comprises a solvent consisting of one ormore of the following: benzyl alcohol, pentylene glycol, isopropylalcohol, hexylene glycol, butylene glycol, and dipropylene glycol. 41.The method of claim 27 further comprising: one or more stabilizers; oneor more moisturizers; one or more emulsion stabilizers; one or moreemulsifying agents; one or more conditioning agents; one or moreantioxidants; and one or more pH adjuster.
 42. The method of claim 41wherein the moisturizer comprises propylene glycol.
 43. The method ofclaim 41 wherein the emulsion stabilizer comprises a mixture of cetyland stearyl alcohols.
 44. The method of claim 41 wherein the emulsifyingagent comprises Ceteareth-20.
 45. The method of claim 41 wherein theconditioning agent comprises stearalkonium chloride.
 46. The method ofclaim 41 wherein the antioxidant comprises BHT.
 47. The method of claim41 wherein the pH adjuster comprises sodium hydroxide.
 48. The method ofclaim 41 further comprising one or more viscosity increasing agents. 49.The method of claim 48 wherein the viscosity increasing agent comprisesa mixture of cetyl and stearyl alcohols.
 50. A method of controllingadults and ova of the species of order Anoplura by topically applying toone or more of skin and hair a composition comprising: an effectiveamount of one or more agents having pediculicidal and ovacidalproperties in solution; wherein the agents comprise a chemical structureof:

and one or more stabilizers.
 51. A method of controlling adults and ovaof the species of order Anoplura by topically applying to one or more ofskin and hair a composition comprising: about 44% water; about 1.1%PVM/MA decadiene crosspolymer; About 3% propylene glycol; About 3%cetearyl alcohol; About 0.9% ceteareth-20; About 4.17% stearalkoniumchloride; About 10% benzyl alcohol; About 6% hexylene glycol; About 4%pentylene glycol; About 20% isopropyl alcohol; About 2.19% mixture ofspinosyn A and spinosyn D in an approximate 85:15 weight ratio; About0.1% BHT; and 1.29% sodium hydroxide (10% solution).
 52. A method forsolubilizing agents having pediculicidal and ovacidal propertiescomprising: Combining one or more solvents and an effective amount ofone or more agents having pediculicidal and ovacidal properties; whereinthe agents comprise a chemical structure of:


53. The method of claim 52 further comprising adding one or morestabilizers.
 54. The method of claim 52, wherein the agents consist ofone or more of the following: spinosad, spinosyn, spinosyn A, spinosynD, any component produced by the Saccharopolyspora spinosa species and acombination thereof.
 55. The method of claim 52, wherein R comprises H.56. The method of claim 52, wherein R comprises CH₃.
 57. The method ofclaim 52, wherein R comprises a mixture of H:CH₃.
 58. The method ofclaim 52, wherein R comprises a mixture of H:CH₃ wherein the relativestructures are in a weight ratio of approximately 85:15.
 59. The methodof claim 52, wherein the agents comprise greater than about 0 to about10 percent of the composition.
 60. The method of claim 52 wherein theagents comprise between about 0.5 to about 5 percent of the composition.61. The method of claim 53, wherein the stabilizers comprise one or moreof the group consisting of PVM/MA Decadiene crosspolymers,acrylates/aminoacrylates C10-30 Alkyl PEG-20 Itaconate copolymer, longchain acyl derivatives, alkanolamides, esters of long chain of fattyacids, alkyl dimethylamine oxides, methylcellulose, hydroxybutylmethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose,hydroxyethyl cellulose, distearyl phthalic amide, di(hydrogenated)tallow phthalic amide, primary amines with a fatty alkyl moiety of atleast 16 carbons, polyacrylic acids, polysaccharide gums, colloidalclays and colloidal silica.
 62. The method of claim 53, wherein thestabilizer comprise PVM/MA decadiene crosspolymers.
 63. The method ofclaim 53 wherein the stabilizers comprises about 0.5 to about 1.5percent of the composition.
 64. The method of claim 53 wherein thestabilizers have a particle size of <75μ.
 65. The method of claim 52further comprising adding a solvent consisting of one or more of thefollowing: benzyl alcohol, pentylene glycol, isopropyl alcohol, hexyleneglycol, butylene glycol, and dipropylene glycol.
 66. The method of claim52 further comprising adding one or more stabilizers; one or moremoisturizers; one or more emulsion stabilizers; one or more emulsifyingagents; one or more conditioning agents; one or more antioxidants; andone or more pH adjuster.
 67. The method of claim 66 wherein themoisturizer comprises propylene glycol.
 68. The method of claim 66wherein the emulsion stabilizer comprises a mixture of cetyl and stearylalcohols.
 69. The method of claim 66 wherein the emulsifying agentcomprises Ceteareth-20.
 70. The method of claim 66 wherein theconditioning agent comprises stearlkonium chloride.
 71. The method ofclaim 66 wherein the antioxidant comprises BHT.
 72. The method of claim66 wherein the pH adjuster comprises sodium hydroxide.
 73. The method ofclaim 66 further comprising adding one or more viscosity increasingagent.
 74. The method of claim 73 wherein the viscosity increasing agentcomprises a mixture of cetyl and stearyl alcohols.